Added: Jul 16, 2008 1:32 pm
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. Statement of Work (SOW)
For
Human Use Testing of Computer Assisted Resuscitation Algorithm (CARA)
1.0 Objective:
This contract request is for highly specialized software engineering support for proposal D42_024_2005_WRAIR Evaluation of Closed Loop Control of Fluid Infusion During Resuscitation in the Compensatory and Decompensatory Phases of Hemorrhagic Shock. Work under this contract will provide 1) critical documentation required to obtain an investigational device exemption (IDE) from the Food and Drug Administration (FDA), 2) software programming interface support to facilitate planned human use trials and 3) programmatic revisions that come out of these trials, 4) development of subsequent CARA software that can be implemented in physiological monitoring systems currently under development by the Army.
CARA is an in-house developed fluid infusion control software system meant to resuscitate and maintain blood pressure. This closed loop system has been developed using highly specialized formal methods software engineering to facilitate FDA approval. Failure to award will result in increased delays in development, FDA approval and testing as well as potentially compromising patient safety. This contract will be paid from USAMRMC FAD dollars.
2.0 Technical Requirements:
The contractor shall provide technical support to MRMC in the area of consultation, development, computer programming and documentation of the Computer Assisted Resuscitation Algorithm (CARA) software system. The contractor must be expert in the Cleanroom software engineering process as CARA has been developed using this formal software development system. The contractor must understand closed-loop control systems and have a rudimentary knowledge of the Army medical practice and resuscitation physiology. It is envisioned that CARA will be written in C++ language and operate on a Unix-based computer. The contractor must maintain an on-line file of updated files for easy review. These files include, but are not limited to, the following documents: requirements, requirements rectification analysis, software state diagrams, software source code, software version control, test plan, software bug listing (to include description, status, how bug was fixed and software version that includes the fix). These files must be accessible by the contractor and the government at all times.
3.0 Deliverables:
Deliverables shall consist of assorted reports, lists, and software, to include source code as well as executable code. All documentation and other materials shall be presented in draft form and upon receipt of Government comments, shall be finalized and delivered. These deliverable artifacts are: hazards analysis report, version 2 software code (source and executable), revised requirements list, revised enumeration list, test modeling script list, updated code (source and executable) and revised hazard analysis.
4.0 Qualification Requirements:
The contractor must be expert in the Cleanroom software engineering process since CARA has been developed using this formal software development system. The contractor must provide a facility, computer equipment and telecommunications capable of completing the tasks. The candidate should be able to submit a list of past projects documenting their use and application of Cleanroom Software Engineering. The candidate must be expert in software development, bug tracking and version control.
5.0 Place and Period of Performance:
a. Place of Performance: Work will be performed in the contractors facility.
b. Period of Performance: The period of performance shall cover the period from issue of contract until 31 December 2009.
c. Work Days: The contractor may arrange their own work schedule. It is expected that the contractor will be available for prearranged teleconferences during normal government business hours, 8:00 a.m. to 5:00 p.m. ET, Monday through Friday excluding federal holidays. It is up to the contractor to provide, in advance, times and dates of any vacation time.
d. Travel: No travel is expected for this contract.
6.0 Restrictions: There are no known existing or potential conflicts of interest associated with the statement of work. The reports and documentation resulting from this task may be utilized in future competitive procurements.
8.0 Government Furnished Equipment:
The government will furnish any necessary records and documents needed to assist in completion of the work. These documents include artifacts from original CARA development such as requirements, specifications, enumeration lists,
9.0 Security Clearance: No security clearance is required.
10.0 Contracting Officer's Technical Representative (COTR)
Name: Stephen Van Albert
Acting Chief, Dept. of Resuscitative Medicine
Address: To the Commander
Walter Reed Army Institute of Research
Attn: Stephen Van Albert, MCMR-UWH-A
503 Robert Grant Avenue, Dept. of Resuscitative Medicine Forest Glen Annex
Silver Spring, MD 20910-7500
DSN: 285-9939
Commercial: (301) 319-9939
